Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BD FACS SAMPLE PREP ASSISTANT III

K-Number: K131301 · 2013-08-02

ApplicantBecton, Dickinson & CO
Decision Date2013-08-02
Product CodePER
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BD FACS SAMPLE PREP ASSISTANT III is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2013-08-02 under 510(k) number K131301. The device is classified under product code PER. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD FACS SAMPLE PREP ASSISTANT III?

BD FACS SAMPLE PREP ASSISTANT III is a medical device that received FDA 510(k) clearance on 2013-08-02. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K131301.

When did BD FACS SAMPLE PREP ASSISTANT III receive FDA 510(k) clearance?

BD FACS SAMPLE PREP ASSISTANT III received FDA 510(k) clearance on 2013-08-02, under 510(k) number K131301.

Who is the listed applicant for BD FACS SAMPLE PREP ASSISTANT III?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD FACS SAMPLE PREP ASSISTANT III?

The FDA product code for BD FACS SAMPLE PREP ASSISTANT III is PER.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Becton, Dickinson & CO as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitK160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitK133140BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSVK133138BD Veritor™ System Flu A+B AssayK130268BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAYK131358BD PEN NEEDLE

View all 190 devices →

Related Devices (Code: PER)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130253TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATIONBeckman Coulter, Inc.K050191MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWAREBecton, Dickinson & CO

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑